Platelet rich plasma in Leprosy neuropathy

Phase 3

Completed

• Conditions: Health Condition 1: A309- Leprosy, unspecified

• Registration Number: CTRI/2022/11/046962
• Lead Sponsor: AIIMS Bhopal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-12-30
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Known case of Hansen’s disease on or post treatment with Multi drug therapy

2. Age: =18 years

3. Patients of Hansen’s disease with peripheral neuropathy involving Ulnar and/ or

Common Peroneal Nerve with residual impairment

4. Willingness to participate in study (informed written consent)

5. Willingness to forego any other concomitant treatment modality

Exclusion Criteria

1. Hansen’s disease diagnosed for more than three years duration.

2. Signs of active inflammation or abscess around the Ulnar or Common Peroneal

Nerve

3. Diagnosed case of active lepra reaction

4. Infection at the site of injection

5. Reduced range of motion of knee, elbow, wrist or ankle

6. Abnormal radiograph of elbow joint and knee joint of the affected side

7. Received local steroid injection within 6 months, NSAIDS within one week prior

to intervention or on systemic steroids more than 20 mg daily

8. Abnormal haemoglobin or blood count (platelet count < 50x 109

, Hb <10

g/dl,Mean platelet volume >12.3 fl)

9. Use of anti-platelet medications

10. Uncontrolled Diabetes Mellitus (FBS >125 mg/dl or PPBS >200 mg/dl)

11. Known case of severe cardiac, liver or renal disease

12. Pregnancy or lactation

13. Unwillingness to participate in study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
two point discrimination testTimepoint: 0,6, 12 weeks

Secondary Outcome Measures

Name	Time	Method
total area of sensory impairment, Nerve conduction study, dynamometry and manual muscle power testing, SALSA scale scoreTimepoint: 0,6, 12 weeks